CLINICAL & PIPELINE·Drug Approval
Genus Secures FDA Approval for Oral Potassium Chloride Solution (NDA208019)
Genus Lifesciences Inc. secured FDA approval for its Potassium Chloride oral solution (NDA208019) on August 19, 2015. This Type 7 approval formalized market access for Genus's 10MEQ, 15MEQ, 20MEQ, and 40MEQ formulations, an essential electrolyte. Subsequent labeling updates in 2019 and 2020 reinforce regulatory compliance. This event impacts procurement strategies and competitive dynamics in the established electrolyte market.
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